Become a proficient biomedical translator through the life cycle of a new drug - Part II
Course summary
Description Learning about the process that a drug has to go through till it can reach market is a complex web that the translator needs to know to address the translation task successfully. It takes on average 12 years and over US$350 million to get a new drug from the laboratory onto the pharmacy shelf. Once a company develops a drug, it undergoes around three and a half years of laboratory testing, before an application is made to the U.S. Food and Drug Administration (FDA) to begin testing the drug in humans. Only one in 1000 of the compounds that enter laboratory testing will ever make it to human testing. If the FDA gives the green light, the "investigative" drug will then enter three phases of clinical trials. The company then submits an application (usually about 100,000 pages) to the FDA for approval, a process that can take up to two and a half years. After final approval, the drug becomes available for physicians to prescribe. At this stage, the drug company will continue to report cases of adverse reactions and other clinical data to the FDA. Understanding this cycle is vital for medical translators and, once digested, it can become an endless source of reference, reliable sources of information and terminology, and a valuable self-catering training tool. This training course is divided into 2 parts, in order to cover broader content. Training plan: Target audience Freelance translators with some experience in biomedical translation (especially in the clinical trial arena) and want-to-be ones. Learning objectives Trainees will learn about: - The steps from test tube to new drug application review - Regulations and authority agencies - Procedures and related materials - Sources of linguistic references - Translation strategies Prerequisites Some previous experience in medical translation Program Click to expand - Background refresh from part I - Clinical studies (cont.) - New drug application review - Samples - Resources - Conclusions Registration and payment information (click to expand) Click to expand Price: 25.00 USD Click on the buy button on the right to purchase your seat Participation fee includes unlimited access to the recording and handouts provided by the trainer. How do I purchase the video? To purchase your seat at this session please click on the "buy" button. After your payment is received, your status will be changed to “registered and paid” and an invoice and receipt of payment will be sent to you for your records. How do I access the video? Once the payment is processed you will be able to watch the video here. Where can I find a certificate of attendance? A certificate of attendance can be issued upon training completion and as per your request. A certificate of attendance can be downloaded at http://www.proz.com/profile/?show_mode=standard#trainings Created by Luciana Ramos View feedback | View all courses
General discussions on this training
| Course registration To view pricing and payment options for this course, you must login to your ProZ.com account. Do you have any questions about ProZ.com training? Read the training FAQ » Still need help? Submit a support request » Would you like to share your thoughts about the ProZ.com training platform? Click here to discuss this feature in the forums » Send a colleague information about this course Feedback on this course (3)
|
You can request verification for native languages by completing a simple application that takes only a couple of minutes.
Review native language verification applications submitted by your peers. Reviewing applications can be fun and only takes a few minutes.
View applications